Overview
What you will study
Patient safety and good quality of care are strongly linked to the processes used in healthcare. The use of technology, new or old, has been part of healthcare for decades, and medical applications have been the driving force behind developing new technologies.
After completing the Quality Managment Systems and Regulatory Framework in Clinical Engineering course, provided by KTH Royal Institute of Technology, the participant will be able to:
- analyse the current regulatory framework for medical technology operations in detail
- identify the necessary parts in a quality management system
- give details for developing a quality management system for medical technology operations
- identify critical risks in medical technology operations
Programme Structure
The program focuses on:
- applicable European directives, national laws, regulations and directions including MDR
- liability issues
- applicable standards
- the concept of quality
- quality management system for medical technology operations
- patient safety when using medical devices
- handling accidents and incidents
- adverse event analysis
- risk management in the use and handling of medical devices
Key information
Duration
- Full-time
- 3 months
Start dates & application deadlines
- StartingApplication deadline not specified.
Language
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Credits
Delivered
Campus Location
- Stockholm, Sweden
Disciplines
Bio & Biomedical Engineering Operations and Quality ManagementWhat students do after studying
Academic requirements
We are not aware of any specific GRE, GMAT or GPA grading score requirements for this programme.
English requirements
Prepare for Your English Test
AI-powered IELTS feedback. Clear, actionable, and tailored to boost your writing & speaking score. No credit card or upfront payment required.
- Trusted by 300k learners
- 98 accuracy using real exam data
- 4.9/5 student rating
Other requirements
General requirements
- Bachelor’s degree in biomedical science or at least 2 years work experience in healthcare.
- English B/English 6
Student Insurance via Studyportals Partner
Make sure to cover your health, travel, and stay while studying abroad. Even global coverages can miss important items like Additional medical costs, Repatriation, Liability etc. Make sure your student insurance covers your needs.
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Get your student insurance nowStarting from €0.53/day, free cancellation any time.
Remember, countries and universities may have specific insurance requirements. To learn more about how student insurance work at KTH Royal Institute of Technology and/or in Sweden, please visit Student Insurance Portal.
Tuition Fees
Living costs
Stockholm
The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.